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Experimental combo targets Tough-to-Treat colorectal cancer

NCT ID NCT06654037

Recruiting now Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-phase trial is testing whether combining two drugs—abemaciclib and 5-fluorouracil—is safe and tolerable for people with advanced colorectal cancer that has spread and stopped responding to standard treatments. About 39 participants will receive the combination to find the best dose and watch for side effects. The goal is to see if this approach can control the disease when other options have failed.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
abemaciclib and 5-fluorouracil
What this could lead to
If this combination proves safe and effective, it could offer a new treatment option for patients with advanced colorectal cancer that has stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 39 participants, so the main goal is safety and dosing, not proof of benefit. The cancer is aggressive and heavily pre-treated, so even if safe, the combination may not shrink tumors or extend survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC MICROSATELLITE STABLE COLORECTAL CARCINOMA REFRACTORY MICROSATELLITE STABLE COLORECTAL CARCINOMA STAGE IV COLORECTAL CANCER AJCC V8

Contacts and locations

Locations

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    RECRUITING

    The Bronx, New York, 10461, United States

  • Montefiore Medical Center-Weiler Hospital

    RECRUITING

    The Bronx, New York, 10461, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

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